2. Legal framework – EU legislation - EudraLex

Volume 2 contains a list of regulatory guidelines related to procedural and regulatory requirements such as renewal procedures, dossier requirements for Type IA/IB variation notifications, summary of product characteristics (SmPC), package information and classification for the supply, readability of the label and package leaflet (PL) requirements.

Volume 2 is presented in three parts and is regularly updated:

• Volume 2A dealing with procedures for marketing authorisation
• Chapter 1 - Marketing Authorisation (updated version - July 2019)
• Chapter 2 - Mutual Recognition (updated version - February 2007)
• Chapter 3 - Union Referral Procedures (updated version - November 2018)
• Chapter 4 - Centralised Procedure (deleted - July 2015). This chapter has been deleted because the information related to the centralised procedure is now provided on the EMA website directly
  Chapter 5 - Guidelines of 16 May 2013 on the details of the various categories of variations, and on the operation of the procedures
• Chapter 6 - Community Marketing Authorisation (updated version - November 2005)

• Volume 2B dealing with the presentation and content of the application dossier incorporating the Common Technical Document (CTD) (May 2008).
• Electronic Application Forms The use of the electronic Application Forms (eAF) is mandatory for all procedures from 1 January 2016. The eAFs must be used for all applications: authorisations, variations and renewals.
• Electronic Common Technical Document (eCTD) EU Module 1 Specification

• Volume 2C dealing with regulatory guidelines